The US Food and Drug Administration (US) announced the creation of a Rare Disease Innovation Hub to speed development of new treatments, integrate regulation of drugs and biologics, and engage patient advocacy communities.
The Rare Disease Innovation Hub, or “the Hub”, will focus on diseases that are not fully understood and where development of treatments is “particularly challenging”, the agency explained. It will be co-led by Center for Biologics Evaluation and Research Director Peter Marks and Center for Drugs Evaluation and Research (CDER) Director Patrizia Cavazzoni.
The agency is also recruiting for a new senior leader – Associate Director for Rare Disease Strategy – who will serve as a single contact point of communication and engagement with rare diseases stakeholder groups. The leader will oversee a new joint, integrated CBER/CDER model “to accelerate development of treatments across modalities, including drugs, cell, gene therapies and other biologics”. As part of the job, they will create a rare disease strategic agenda action plan driven by the needs of patient communities…
